Houtz v. Encore Medical Corporation et al
Filing
20
MEMORANDUM (Order to follow as separate docket entry.Signed by Honorable Matthew W. Brann on 12/10/14. (km)
IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF PENNSYLVANIA
HELEN E. HOUTZ,
Plaintiff,
v.
ENCORE MEDICAL
CORPORATION, ENCORE
MEDICAL, L.P., DJO SURGICAL
and DJO INCORPORATED,
Defendants.
:
:
:
:
:
:
:
:
:
:
:
:
Case No. 4:14-cv-0536
(Judge Brann)
MEMORANDUM
December 10, 2014
Defendants Encore Medical Corporation, Encore Medical, L.P., DJO
Incorporated, and DJO Surgical (hereinafter, “Defendants”) filed a Motion to
Dismiss Plaintiff Helen E. Houtz’s Amended Complaint for failure to state a claim
upon which relief can be granted pursuant to Rule 12(b)(6) of the Federal Rules of
Civil Procedure. Defs.’ Mot. Dismiss, May 7, 2014, ECF No. 11 (hereinafter
“Defs.’ Mot.”). Plaintiff’s Amended Complaint, filed April 25, 2014, alleges one
count for negligence, based on various theories of liability, and one count for
manufacturing defect based upon a theory of strict liability. Pl.’s Compl., Apr. 25,
2014, ECF No. 10 (hereinafter “Pl.’s Compl.”). Defendants seek to dismiss
Plaintiff’s Amended Complaint against them in its entirety. This Court retains
1
diversity jurisdiction pursuant to 28 U.S.C. § 1332. Consequently, Pennsylvania
substantive law applies. See, e.g., Erie R. Co. v. Tompkins, 304 U.S. 64, 91-92
(1938).
For the reasons discussed, Defendants’ Motion to Dismiss is granted in part
and denied in part. Insofar as Plaintiff’s Amended Complaint asserts a claim for
negligent failure to test and negligent sale in Count I, those claims are dismissed
with prejudice. Insofar as Plaintiff’s Amended Complaint asserts a claim for
negligent failure to warn and negligent design in Count I, those claims are
dismissed without prejudice with leave to file a second amended complaint in
accordance with this Court’s decision. Defendants’ Motion to Dismiss is denied
with regard to Plaintiff’s claim in Count II for manufacturing defect based upon a
theory of strict liability.
I. BACKGROUND
On February 24, 2014, Plaintiff initiated the above-captioned civil action by
filing a Complaint in the Court of Common Pleas of Centre County, Pennsylvania.
On March 30, 2014, Defendants removed the case to this Court pursuant to 28
U.S.C. §§ 1332(a), 1441(a), and 1446. On April 25, 2014, Plaintiff filed an
Amended Complaint with this Court alleging one count of negligence based upon
various theories of liability and one count of strict liability due to a manufacturing
defect. On May 7, 2014, Defendants moved to dismiss Plaintiff’s Amended
2
Complaint in its entirety. The following allegations are taken from Plaintiff’s
Amended Complaint and are accepted as true for the purposes of the instant
motion.
This case arises from the implantation and subsequent failure of an artificial
knee replacement device produced by the Defendants and implanted into the
Plaintiff on or about February 7, 2000 during a bilateral knee replacement surgery.
Pl.’s Compl. ¶ 8. The surgery was performed by Kenneth Cherry, M.D., at the
Center Valley Community Hospital, State College, Pennsylvania. Id. ¶ 6, 8. Prior
to the surgery, Plaintiff was provided no indication or warning by Defendants that
the artificial knee’s post tibial insert and/or polyethylene was destined to fail or had
any particular life expectancy. Id. ¶ 17. Though the knee replacements initially
functioned satisfactorily1, in April 2011, Plaintiff experienced an audible popping
sensation in her left knee as she stood up from a sitting position. Id. ¶ 10. This
caused her knee to become unstable and painful, leading her to seek medical
attention at Mount Nittany Medical Center. Id. ¶ 10.
Once again, Dr. Cherry examined the Plaintiff and concluded that Plaintiff
had suffered a failed tibial post, which is the portion of the knee implant that
attaches to the lower half of an individual’s leg. Id. ¶ 11-13. As a result, Dr.
Cherry ultimately conducted a revision of the left tibial insert, the component of
1
In her Brief in Opposition to Defendants’ Motion to Dismiss, Plaintiff asserts that the implant in her right knee had
previously failed and needed to be replaced in October 2001, although, curiously, she asserts no such thing in her
Amended Complaint.
3
the knee that had failed. Id.¶ 14. In his explanation of the failure, Dr. Cherry
reported that “[t]he post is missing and marked irregularity of this region is noted. .
. . The smaller fragment appears to represent the missing post and is markedly
irregular at one end.” Id. ¶ 16. As a result of the failure of the tibial post and the
subsequent surgery, Plaintiff has suffered pain, discomfort, and instability in her
left knee, and past and ongoing medical treatment, which may continue
indefinitely. Id. ¶ 23(a)-(f).
II. DISCUSSION
A. Motion to Dismiss Standard
When considering a motion to dismiss under Federal Rule of Civil
Procedure 12(b)(6), a court must view all allegations stated in the complaint as true
and construe all inferences in the light most favorable to plaintiff. Hishon v. King
& Spaulding, 467 U.S. 69, 73 (1984); Kost v. Kozakiewicz, 1 F.3d 176, 183 (3d
Cir. 1993). However, “the tenet that a court must accept as true all of the [factual]
allegations contained in the complaint is inapplicable to legal conclusions.”
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (internal citations omitted). In ruling
on such a motion, the court primarily considers the allegations of the pleading, but
is not required to consider legal conclusions alleged in the complaint. Kost, 1 F.3d
at 183. “Threadbare recitals of the elements of a cause of action, supported by
mere conclusory statements, do not suffice.” Iqbal, 556 U.S. at 678. At the
4
motion to dismiss stage, the court considers whether plaintiff is entitled to offer
evidence to support the allegations in the complaint. Maio v. Aetna, Inc., 221 F.3d
472, 482 (3d Cir. 2000).
A complaint should only be dismissed if, accepting as true all of the
allegations in the amended complaint, plaintiff has not pled enough facts to state a
claim to relief that is plausible on its face. Bell Atlantic Corp. v. Twombly, 550
U.S. 544, 561 (2007). “Determining whether a complaint states a plausible claim
for relief will . . . be a context-specific task that requires the reviewing court to
draw on its judicial experience and common sense.” Iqbal, 556 U.S. at 663-664.
“In considering a Rule 12(b)(6) motion, we must be mindful that federal
courts require notice pleading, as opposed to the heightened standard of fact
pleading.” Hellmann v. Kercher, No. 07-1373, 2008 WL 1969311 at * 3 (W.D. Pa.
May 5, 2008) (Lancaster, J.). Federal Rule of Civil Procedure 8 "requires only a
‘short and plain statement of the claim showing that the pleader is entitled to relief,'
in order to 'give the defendant fair notice of what the…claim is and the grounds on
which it rests,'" Bell Atlantic Corp. v. Twombly, 550 U.S. at 554 (quoting Conley v.
Gibson, 355 U.S. 41, 47 (1957)). However, even under this lower notice pleading
standard, a plaintiff must do more than recite the elements of a cause of action, and
then make a blanket assertion of an entitlement to relief. See Hellmann, 2008 WL
1969311 at *3. Instead, a plaintiff must make a factual showing of his entitlement
5
to relief by alleging sufficient facts that, when taken as true, suggest the required
elements of a particular legal theory. See Twombly, 550 U.S. at 561. “[W]here the
well-pleaded facts do not permit the court to infer more than the mere possibility of
misconduct, the complaint has alleged - - but it has not “shown” - - “that the
pleader is entitled to relief.” Iqbal, 556 U.S. at 679 (quoting Fed. R. Civ. P. 8(a)).
The failure-to-state-a-claim standard of Rule 12(b)(6) “streamlines litigation
by dispensing with needless discovery and factfinding.” Neitzke v. Williams, 490
U.S. 319, 326-27 (1989). A court may dismiss a claim under Rule 12(b)(6) where
there is a “dispositive issue of law.” Id. at 326. If it is beyond a doubt that the
non-moving party can prove no set of facts in support of its allegations, then a
claim must be dismissed “without regard to whether it is based on an outlandish
legal theory or on a close but ultimately unavailing one.” Id. at 327.
B. Count I Negligence
In her Amended Complaint, Plaintiff asserts one count for negligence based
on various theories of liability. As only two of these theories are even viable
theories of negligence under Pennsylvania law, this Court will address each theory
in turn.
1.
Negligent Failure to Test
One theory on which Plaintiff bases her claim of negligence is on
6
Defendants’ “failure to properly test and/or inspect the Encore knee to determine
whether it could be used for its intended purpose without injury to those persons
who were implanted with such device.” Pl.’s Compl. ¶ 21(c). Defendants argue
that, to the extent Plaintiff is asserting a claim for negligent failure to test, it should
be dismissed because such a claim is not recognized in Pennsylvania. Plaintiff, for
her part, does not respond to this argument in her opposing brief.
Pennsylvania courts have explicitly stated that negligent failure to test is not
a viable cause of action, and “[they] have found no ‘duty to test’ that would be the
basis of such a claim.” Viguers v. Philip Morris USA, Inc., 837 A.2d 534, 541 (Pa.
Super. 2003) (citing Oddi v. Ford Motor Co., 234 F.3d 136, 143-44 (3d Cir. 2000)
(plaintiff’s negligent failure to test claim is nothing more than a routine products
liability case)). Consequently, to the extent that Plaintiff’s Amended Complaint
asserts a claim for negligent failure to test, that claim is dismissed with prejudice.
2.
Negligent Sale
Another theory on which Plaintiff bases her claim of negligence is on
Defendants’ “[f]ailure to . . . sell the Encore knee in a manner so as to render [it]
safe for [its] intended purpose.” Pl.’s Compl. ¶ 21(a). Although apparently unsure
exactly what claim Plaintiff is asserting with this allegation, Defendants
nevertheless argue that, to the extent Plaintiff intends to assert a “negligent
7
marketing claim,” Pennsylvania law does not recognize this claim either. Again,
Plaintiff fails to respond to this argument in her opposing brief.
The Court is similarly confused as to what claim Plaintiff is trying to make
in this regard. Because of Plaintiff’s failure to defend her claim, the Court will
also address the claim in the context of negligent marketing. Defendants are
correct in their contention that Pennsylvania courts do not recognize this type of
claim. See Wolfe v. McNeil-PPC, Inc., 773 F.Supp.2d 561, 570 (E.D.Pa. 2011);
see also Owens v. Wyeth, No. 185 EDA 2009, 2010 WL 2965014, at *6 (Pa. Super.
Ct. July 26, 2010). Pennsylvania does, however, recognize one narrow exception
to this broad prohibition on negligent marketing claims for circumstances in which
a drug is promoted in such a way as to negate otherwise-adequate warnings. See
Wolfe, 773 F.Supp.2d at 570-71; see also Baldino v. Castagna, 478 A.2d 807, 810
(1984).
However, Plaintiff pleads absolutely no facts regarding Defendants’
advertising or marketing practices with regard to the artificial knee at issue and
therefore does not make any averments that Defendants’ advertising negated the
warnings that Defendants provided about the product. In fact, Plaintiff actually
alleges that Defendants made no warnings to her about the artificial knee at all,
precluding any prospect that this narrow exception to the prohibition on negligent
marketing claims would apply. Consequently, insofar as Plaintiff’s Amended
8
Complaint asserts a claim for negligent marketing, that claim is also dismissed
with prejudice.
3.
Negligent Failure to Warn
Yet another theory on which Plaintiff bases her claim of negligence is the
Defendants’ “[f]ailure to provide sufficient warnings as to: (1) the reasonably
foreseeable defects in the Encore knee; and (2) the reasonably foreseeable dangers
resulting from the implantation and/or usage of the Encore knee.” Pl.’s Compl. ¶
21(b). Defendants argue first that Plaintiff’s allegations in her Amended
Complaint relating to this theory of liability are conclusory and devoid of any
factual support, and therefore do not satisfy federal pleading standards under
Twombly and Iqbal. They next contend that Plaintiff’s negligent failure to warn
claim is only viable if she pleads the warning that the Defendants should have
given and that an alternative warning would have affected her choice to use
Defendants’ artificial knee replacement. Finally, Defendants argue that even if
Plaintiff did adequately plead her claim under federal pleading standards, her claim
is barred by Pennsylvania’s learned intermediary doctrine.
Plaintiff responds that a recent case from the Supreme Court of
Pennsylvania, Lance v. Wyeth, 85 A.3d 434 (Pa. 2014), has overruled
Pennsylvania’s learned intermediary doctrine and therefore manufacturers of
9
pharmaceutical drugs and medical devices can face direct liability for their failure
to warn the end-consumer of the risks associated with the drug or device.
To plead a claim of negligence, including a claim for negligent failure to
warn, a plaintiff must allege that the manufacturer owed a duty to the plaintiff; that
the manufacturer breached that duty; and that such breach was the proximate cause
of plaintiff’s injuries. See Salvio v. Amgen, Inc., 810 F.Supp.2d 745, 752-53
(W.D.Pa. 2011). In her Amended Complaint, Plaintiff alleges that Defendants had
a duty to end-user patients, including Plaintiff, “to exercise reasonable care in the
design, formulation, manufacture, marketing, promotion, sale, and/or distribution
of the Encore knee devices into the stream of commerce so that it would be safely
used in a manner and for a purpose for which they were made.” Pl.’s Compl. ¶ 20.
She next alleges that Defendants breached that duty by failing to warn her of
foreseeable defects in the artificial knee and of foreseeable dangers from the knee’s
implantation. Pl.’s Compl. ¶ 21(b). Finally, she alleges that the defects in the knee
were foreseeable to the Defendants and that she suffered injury as a result of their
failure to warn her. Pl.’s Compl. ¶ 23. In so pleading, Plaintiff has given the
Defendants “fair notice of what the . . . claim is and the grounds on which it rests.”
Conley, 355 U.S. at 47.
Defendants’ argument that Plaintiff did not address the warning that was
provided and failed to state what warning Defendants should have given is
10
unavailing. Plaintiff has adequately stated that Defendants gave her no warning at
all, and further, that they should have warned her that the tibial post was defective
and had a high risk of failure. Moreover, Defendants’ argument that Plaintiff must
have pled that an alternative warning would have prevented her from utilizing the
device is similarly unavailing. Whether or not a different warning would have
affected her choice to use the product is not a separate element of a negligence
claim that Plaintiff is required to plead in her complaint. Rather, this aspect of the
claim goes only to a causation analysis. As mentioned, Plaintiff has adequately
pled causation for the purpose of the present motion to dismiss. Accordingly,
Plaintiff need not plead that a different warning would have altered her decisionmaking.
However, Defendants’ final argument that the learned intermediary doctrine
applies in this case to bar Plaintiff’s claim for negligent failure to warn has merit.
The learned intermediary doctrine states that “the warnings which are required to
be given by the manufacturer [of a prescription drug] must be directed to the
physician, not the patient-consumer.” Daniel v. Wyeth Pharms., Inc., 15 A.3d 909,
924 (Pa. Super. Ct. 2011) (quoting Taurino v. Ellen, 579 A.2d 925, 927 (Pa. Super.
Ct. 1990). Though the original cases detailing the doctrine dealt only with
manufacturers of prescription drugs, it has since been extended to apply to medical
devices as well. See Mazur v. Merck & Co, Inc., 964 F.2d 1348, 1355 (3d Cir.
11
1992); see also Linegerger v. Wyeth, 894 A.2d 141, 150 (Pa. Super. Ct. 2006)
(citing Rosci v. AcroMed, Inc., 669 A.3d 959, 968-69 (Pa. Super. Ct. 1995).
The rationale for the doctrine is that the prescribing physician is more apt to
be aware of the patient and his circumstances, including the patient’s history,
medications, and the amount of the drug that can be safely administered to that
patient. See id. It is therefore the province of the physician “to use his independent
medical judgment, taking into account the data supplied to him from the
manufacturer, other medical literature, and any other sources available to him, and
weighing that knowledge against the personal medical history of his patient,
whether to prescribe a given drug.” Id. As such, the issue in a failure to warn claim
is whether the warning given by the manufacturer to the prescribing physician was
sufficient; the manufacturer is not required to warn the end-consumer. See id.
The Pennsylvania Supreme Court’s decision in Lance v. Wyeth has cast
doubt on whether the learned intermediary doctrine continues to exist as a bar to
recovery against a manufacturer. See generally Lance v. Wyeth, 85 A.3d 434 (Pa.
2014). In that case, the court stated that “some of the underpinnings of the
principle have come into question in light of changed practices in the prescription
drug industry. These include the emergence of direct-to-consumer advertising and
the evolution of the health-care delivery system encompassing new forms of
managed care.” Id. at 457. However, ultimately the Supreme Court chose not to
12
consider the “wisdom of modifications or exceptions to the doctrine,” because the
case before it did not present the issue for consideration. Id.
It is not the province of this Court to extend the law of Pennsylvania and
dispose of a doctrine that is still the law of the state. Furthermore, given the
rationale behind the rule and the explanation offered by the Pennsylvania Supreme
Court as to why “the underpinnings of the principle have come into question,” it is
far from evident to this Court that the Pennsylvania Supreme Court would choose
to discard the doctrine in its entirety. While the Pennsylvania Supreme Court has
signaled its willingness to move away from the doctrine in the context of
pharmaceutical drugs, it has demonstrated no such willingness with regards to
medical devices, which differ from pharmaceutical drugs in many ways, most
notably in that they are not advertised directly to consumers.
As such, Plaintiff can only avoid the application of the learned intermediary
doctrine if she were to allege that the warnings given by Defendants to her
physician were inadequate, not that the warnings provided directly to her were
inadequate. However, nothing in Plaintiff’s Amended Complaint would suggest
this idea. In fact, Plaintiff appears to allege only that Defendants did not provide
sufficient warnings to her directly. Therefore, insofar as her claim is predicated on
a theory of negligent failure to warn, it is dismissed without prejudice with leave to
13
amend to assert, if possible, that Defendants did not adequately warn Plaintiff’s
physician about the risks associated with the artificial knee replacement.
4.
Negligent Design
The final theory of liability that Plaintiff relies upon for her negligence claim
is that of Defendants’ “[f]ailure to design . . . the Encore knee in a manner so as to
render [it] safe for [its] intended purpose.” Pl.’s Compl. ¶ 21(a). Defendants first
argue that Plaintiff has not specified the nature of the alleged product defect. They
next contend that in order to state a claim for negligent design, Plaintiff must plead
that there was an alternative, feasible, safer design available, and must provide
factual support that the alternative design existed at the time Defendants made the
device for Plaintiff. Plaintiff, for her part, counters that she clearly articulated the
design defect present in Defendants’ knee replacement as the spontaneous failure
of the tibial post and polyethylene. She does not, however, respond to the
allegation that she must plead the availability of an alternative, feasible, safer
design.
Defendants’ first argument, that Plaintiff has not adequately specified the
alleged product defect, is unavailing. As already stated, Plaintiff must only plead
enough facts to put the Defendant on notice as to what her claim is and on what
grounds it rests. See Conley, 355 U.S. at 47. Plaintiff has done so here, in alleging
that the tibial post and polyethylene of her artificial knee spontaneously failed.
14
Without discovery, it would be difficult, indeed, for Plaintiff to plead much more
than that.
Furthermore, evidence of an alternative, feasible, safer design is not an
“absolute prerequisite” to the advancement of a design-defect claim. Lance, 85
A.3d at 458 fn. 36. It is an essential element of Plaintiff’s liability case only if her
claim is “predicated on a theory of design defect based upon the availability of an
alternative safer design.” Id. However, it is unclear from Plaintiff’s Amended
Complaint what theory of design defect she is alleging. To the extent that she is
alleging a theory of design defect based upon the availability of an alternative,
safer design, she must plead in her complaint what that alternative, safer design
might be. To the extent, then, that as her negligence claim is predicated on
negligent design, it is dismissed without prejudice with leave to amend to clarify
what theory of design defect she is alleging.
C. Count II Manufacturing Defect
Defendants’ final argument is that Plaintiff has failed to adequately plead a
claim under Count II of her Amended Complaint for a manufacturing defect based
upon a theory of strict liability. Plaintiff responds that she has in fact presented a
sufficient factual basis which demonstrates a plausible claim for relief against
Defendants for strict products liability based upon the failure of the defective knee
replacement. Further, she argues that she is proceeding on a malfunction theory,
15
which does not require specific evidence of the defect but rather allows the factfinder to infer defect based on circumstantial evidence.
Under Pennsylvania law, a plaintiff alleging a manufacturing defect based
upon a theory of strict liability must show that: (1) the product at issue was
defective; (2) the defect was a proximate cause of the plaintiff’s injuries; and (3)
the defect causing injury existed at the time the product left the seller’s hands. See
Bruesewitz v. Wyeth, 561 F.3d 233, 255 (3d Cir. 2009) (citations omitted) (citing
Berkebile v. Brantly Helicopter Corp., 337 A.2d 893, 898 (1975).
In this case, Plaintiff has adequately pled all of the elements of a
manufacturing defect based upon a theory of strict liability. First, she states that
the product at issue, the tibial post and polyethylene, was defective because it
spontaneously failed, necessitating a new knee replacement. Pl.’s Compl. ¶ 12-18.
Further, she asserts that the failure of the tibial post and polyethylene was the
direct cause of her injuries, both physical and financial. Pl.’s Compl. ¶ 31(a)-(f).
Finally, Plaintiff alleges that the defect causing injury existed at the time the
product left the Defendants’ hands. Pl.’s Compl. ¶ 27-28. Consequently, Plaintiff
has adequately pled a claim for a manufacturing defect.
Defendants next argue that to the extent Plaintiff intends to proceed on a
malfunction theory of liability, she must allege that the device is not available.
16
Further, they argue, she must present evidence eliminating reasonable secondary
causes for the accident.
The malfunction theory of liability allows a plaintiff to use circumstantial
evidence, rather than direct evidence, to prove that a product was defective. See
Varner v. MHS, Ltd., 2 F.Supp.3d 584 (M.D.Pa. 2014) (Mannion, J.). Under a
malfunction theory, the plaintiff must raise inference of a defect through (1)
evidence of the occurrence of a malfunction; (2) evidence eliminating
abnormal use; and (3) evidence eliminating reasonable, secondary causes for the
accident. See Walters v. General Motors Corp., 209 F.Supp.2d 481. 486-87
(W.D.Pa. 2002) (citing Woodin v. J.C. Penney Co., 629 A.2d 974, 975 (Pa. Super.
Ct. 1993)). However, the malfunction theory is available only where the product
has been destroyed or is otherwise unavailable. See Barnish v. KWI Bldg. Co., 980
A.2d 535, 539 (2009).
The malfunction theory is a theory of liability which can be used to establish
the inference of a manufacturing defect. It is not a separate cause of action which
must be pled in the complaint. Because Plaintiff adequately pled the three
elements of a claim for manufacturing defect, she does not need to plead anything
additional relating to her malfunction theory of liability at this stage of the
litigation. In fact, it would be nearly impossible for her to prove a negative, that is,
the lack of secondary causes, without first being confronted with what these other
17
potential secondary causes might be. As such, Defendants’ Motion to Dismiss
with regard to Count II of Plaintiff’s Amended Complaint is denied. However, to
the extent that Plaintiff intends to proceed on a malfunction theory at a later stage
in the proceeding, she must prove that the defective product was unavailable.
III. CONCLUSION
Defendants’ Motion to Dismiss is granted in part and denied in part. Insofar
as Plaintiff’s Amended Complaint asserts a claim for negligent failure to test and
negligent sale in Count I, those claims are dismissed with prejudice. Insofar as
Plaintiff’s Amended Complaint asserts a claim for negligent failure to warn and
negligent design in Count I, those claims are dismissed without prejudice with
leave to file a second amended complaint in accordance with this Court’s decision.
Defendants’ Motion to Dismiss is denied with regard to Plaintiff’s claim in Count
II for manufacturing defect based upon a theory of strict liability.
BY THE COURT:
/s Matthew W. Brann
Matthew W. Brann
United States District Judge
18
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?