WILSON et al v. SYNTHES USA PRODUCTS, LLC et al
MEMORANDUM OPINION. SIGNED BY HONORABLE JEFFREY L. SCHMEHL ON 7/15/2015. 7/16/2015 ENTERED AND COPIES E-MAILED.(lbs, )
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
JAMES P. WILSON and JACQUELYN H.
SYNTHES USA PRODUCTS, LLC, SYNTHES
SPINE COMPANY, LP, SYNTHES SPINE, INC.,
SYNTHES USA HQ, INC., and SYNTHES NORTH
Schmehl, J. /s/ JLS
July 15, 2015
Before the Court is the motion to dismiss of Defendants, Synthes USA Products,
LLC, Synthes Spine Company, LP, Synthes Spine, Inc., Synthes USA HQ, Inc., and
Synthes North America, Inc. (“Defendants”). Plaintiffs, James P. Wilson and Jacquelyn
H. Wilson (“Plaintiffs”) have opposed the motion, and Defendants have filed a reply and
a “Notice of Supplemental Authority.” Further, Plaintiffs have filed their own “Notice of
Supplemental Authority.” Having read the parties’ briefing, I will grant Defendants’
motion to dismiss in part and deny it in part.
Plaintiffs filed this products liability action against Defendants in the Philadelphia
County Court of Common Pleas on March 14, 2014, and on August 14, 2014, Defendants
removed the matter to this Court. Thereafter, Defendants filed a Motion to Dismiss,
claiming Plaintiffs’ Complaint does not set forth a plausible cause of action against
Defendants and therefore, should be dismissed. Specifically, Plaintiffs’ Complaint asserts
four claims against Defendants: 1) strict liability; 2) negligence; 3) negligence per se; and
4) loss of consortium. (See Compl.)
STATEMENT OF FACTS
On March 16, 2010, James Wilson’s doctor implanted two N-Hance spinal
fixation rods manufactured by Defendants in an attempt to repair Mr. Wilson’s back
injuries. (Compl. ¶ 13.) In March of 2012, imaging studies showed that the N-Hance rods
had failed and that both rods implanted in Mr. Wilson’s back had broken in a similar
manner. (Compl. ¶ 14.) Plaintiffs allege, in short, that a properly designed and
manufactured spine implant should not bend, fracture or break once implanted, and that
the N-Hance implants did so because of problems at the manufacturing plant and because
of an inherently defective design that made the rods prone to breakage. (Compl. ¶¶ 1517.)
STANDARD OF REVIEW
To survive a motion to dismiss under Rule 12(b)(6), a plaintiff must allege facts
that “ ‘raise a right to relief above the speculative level.’ ” Victaulic Co. v. Tieman, 499
F.3d 227, 234 (3d Cir.2007) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127
S.Ct. 1955, 167 L.Ed.2d 929 (2007.) In determining whether a complaint is sufficient, the
court must accept all factual allegations as true, construe the complaint in the light most
favorable to the plaintiff, and determine whether, under any reasonable reading, the
plaintiff may be entitled to relief. Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir.
2009) (citing Phillips v. County of Allegheny, 515 F.3d 224, 233 (3d Cir. 2008)).
Although “conclusory” or “bare-bones allegations” will not survive a motion to
dismiss, Fowler, 578 F.3d at 210, a complaint may not be dismissed merely because it
appears unlikely that the plaintiff can prove those facts or will ultimately prevail on the
merits. Phillips, 515 F.3d at 231. Nonetheless, to survive a Rule 12(b)(6) motion, the
complaint must provide "enough facts to raise a reasonable expectation that discovery
will reveal evidence of the necessary element." Id. at 234 (quoting Twombly, 550 U.S. at
556) (internal quotations omitted).
Defendants move to dismiss Plaintiffs’ claims due to allegedly insufficiently pled
manufacturing defect claims and negligence claims. Defendants also argue that Plaintiffs’
strict liability claims should be dismissed, claiming that Pennsylvania law bars the
application of strict liability to an allegedly defective medical device. Defendants also
argue that Pennsylvania law does not recognize a negligent marketing claim. For the
reasons that follow, I will dismiss Plaintiffs’ strict liability and negligent marketing
claims. The remainder of Plaintiffs’ claims will be permitted to remain.
A. Strict Liability Claims.
Defendants claim that Plaintiffs’ strict liability claims must be dismissed because
Pennsylvania law does not recognize a strict liability cause of action against the
manufacturer of a medical device, such as the N-Hance rods used on Mr. Wilson. (Def’s
Mtn, p. 3.) Defendants argue that “[p]roduct liability claims against a medical device
company, under Pennsylvania law, can only be brought under a theory of negligence, not
strict liability.” (Id.) Defendants contend that the Pennsylvania Supreme Court has held
that prescription drugs are “unavoidably unsafe” and are therefore excluded from strict
liability claims under Comment k to the Restatement (Second) of Torts § 402A (Hahn v.
Richter, 673 A.2d 888, 891 (Pa. 1996)), and that this reasoning has been consistently
applied by Pennsylvania state and federal courts to medical device cases, leading to a
finding that plaintiffs may not assert strict liability claims against medical device
manufacturers. (Defs’ Mtn, p. 4.)
Comment k of the Restatement (Second) of Torts, §402A states:
There are some products which, in the present state of human knowledge,
are quite incapable of being made safe for their intended and ordinary use.
These are especially common in the field of drugs…Such a product,
properly prepared, and accompanied by proper directions and warning, is
not defective, nor is it unreasonably dangerous.
Restatement (Second) of Torts, § 402A, comment k. Pennsylvania has adopted comment
k of the Restatement (Second) §402A to exempt prescription drugs from the imposition
of strict liability on manufacturers selling these drugs. Hahn v. Richter, 673 A.2d 888,
889-90 (Pa. 1996); Soufflas v . Zimmer, Inc., 474 F.Supp.2d 737, 749 (E.D. Pa. 2007)
(Robreno. J.) (internal quotation omitted). Although the Pennsylvania Supreme Court has
not yet addressed whether comment k extends to prescription medical devices, the
Pennsylvania Superior Court has held that there is “no reason why the same rational[e]
applicable to prescription drugs may not be applied to medical devices.” Creazzo v.
Medtronic, Inc.. 903 A.2d 24, 31 (Pa. Super. 2006). Further, numerous federal courts
have applied the Superior Court’s reasoning in Hahn to medical device cases, finding that
plaintiffs may not assert strict liability claims against manufacturers of medical devices.
Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420 (W.D. Pa. Nov. 10, 2011);
Soufflas v. Zimmer, Inc., 474 F. Supp.2d at 749-750; Parkinson v. Guidant Corp., 315
F.Supp.2d 741, 747 (W.D. Pa. 2004); Kester v. Zimmer Holdings, Inc., No. 10-523, 2010
WL 2696467, at * 9 (W.D. Pa., June 16, 2010) (McVerry, J.); Geesey v. Stryker Corp.,
2010 WL 3069630 (E.D. Pa. Aug. 4, 2010) (Slomsky, J.); Runner v. C.R. Bard, et al, No.
14-5259, 2015 WL 3513424 (E.D. Pa. June 3, 2015) (Dalzell, J.). But see Bergstresser v.
Bristol-Myers Squibb Co., No. 12-1464, 2013 WL 1760525, *3 (M.D. Pa. Apr. 24, 2013)
(allowing a strict liability claim based upon an alleged manufacturing defect in a
prescription drug to proceed); Dougherty v. C.R. Bard, Inc., 2012 WL 2940727 at *2
(E.D. Pa. July 18, 2010) (finding that strict liability claims involving a manufacturing
defect in prescription drug and device cases are not clearly barred in Pennsylvania);
Tatum v. Takeda Pharmaceuticals North America, Inc., No. 12-1114, 2012 WL 5182895,
*2 (E.D. Pa. Oct. 19, 2012) (concluding that strict liability claims for manufacturing
defects in a prescription drug are not prohibited”); Killen v. Stryker Corp., No. 11-1508,
2012 WL 4498865, *4 (W.D. Pa. Sept. 28, 2012) (denying a motion to dismiss the
plaintiff’s strict liability claim for a manufacturing defect in a medical device case); Kline
v. Zimmer Holdings, No. 13-513, 2013 WL 3279797 (W.D. Pa. June 27, 2013)
(permitting a strict liability manufacturing defect claim to proceed against a medical
Defendants rely on Terrell v. Davol, No. 13-5074, 2014 WL 3746532 (E.D. Pa.
July 30, 2014), a recent case in which Judge Slomsky acknowledged that there is a split
among federal courts regarding the application of strict liability in medical device cases
and that some courts have allowed strict liability manufacturing defect claims only to
proceed. Terrell v. Davol, 2014 WL 3746532 at *5. In analyzing this issue, Judge
Slomsky reviewed the relevant case law and determined that the Pennsylvania Supreme
Court had recently resolved this split in Lance v. Wyeth, 85 A.3d 434, 453 (Pa. 2014),
where it reiterated the long-standing principle that all strict liability claims are barred in
prescription drug cases, and failed to exempt a manufacturing defect claim from this bar.
Terrell, 2014 WL 3746532, at *5. Judge Slomsky then predicted that the Pennsylvania
Supreme Court would conclude that all strict liability claims are also barred in medical
device cases. Id.
Plaintiffs argue that in finding no strict liability for medical devices, Terrell was
wrongfully decided, and that instead, I should follow the analysis found in Kline v.
Zimmer Holdings, 2013 WL 3279797, *5 (W.D. Pa. June 27, 2013), which permitted a
strict liability manufacturing defect claim to proceed against a medical device
manufacturer. Plaintiffs fail to provide any real explanation as to why the holding in
Kline should apply to the instant matter as opposed to the holding in Terrell. 1 Plaintiffs
only argument seems to be that medical devices can be “altered or manufactured in
different ways to render them more fit for their purposes,” and therefore should be
“subjected to equal or greater liability than most products.” (Pls’ Response, p. 4.)
(emphasis in original). I find this attempt to distinguish medical devices from prescription
drugs to be unpersuasive, as both medical devices AND prescription drugs could be
manufactured in different ways to make them more fit for their purpose. Prescription
drugs and medical devices are similar in that both are unreasonably dangerous, but should
not be subjected to strict liability because they benefit certain members of society. See
Terrell, supra at *4. Like prescription drugs, medical devices are known to cause possible
harm, but the risks are outweighed by the benefits they provide for patients who need
them. Clearly, the public policy arguments as to both are very similar. Further, the
decision in Kline v. Zimmer Holdings, which Plaintiffs would have me rely upon, predates the decision of the Pennsylvania Supreme Court in Lance v. Wyeth, which
Both cases involved an allegedly defective medical device. Kline involved a hip replacement part, while
Terrell dealt with a mesh implant inserted as part of a hernia repair.
reiterated a bar on all strict liability claims in Pennsylvania as to prescription drugs. 2
Lance, 85 A.3d at 453. Accordingly, I conclude that Defendants’ argument is correct, and
comment k of the Restatement (Second) §402A serves to impose a ban on all strict
liability against medical device manufacturers. Accordingly, I will grant Defendants’
Motion to Dismiss as to Plaintiffs’ strict liability claims.
B. Negligence Claims
Next, Defendants argue that Plaintiffs have failed to adequately plead their
negligence claims under Fed. R. Civ. P. 8(a)(2), and that Plaintiffs have relied on
“conclusory and boilerplate allegations, devoid of any factual support.” (Defs’ Mtn, pp.
5-6.) Specifically, Defendants take issue with Plaintiffs’ pleading of their manufacturing
defect, negligent marketing, negligent design and failure to warm claims. I will analyze
each of these issues in turn.
1. Manufacturing defect claim
Defendants contend that the allegations in Plaintiffs’ Complaint regarding a
manufacturing defect are deficient because they fail to identify how the device deviated
from the manufacturer’s intended design or how the device deviated from other identical
products. (Defs’ Mtn, p. 9.) Plaintiffs’ Complaint alleges that “Defendants also failed to
exercise reasonable care in the manufacture, distribution and sale of the N-Hance System,
because Defendants’ failed to inspect the devices before placing them in interstate
The Kline court relied in part on Dougherty v. C.R. Bard, 2012 WL 2940727, at *4 (E.D. Pa., July 18,
2012) an Eastern District of Pennsylvania case in which the Court declined to bar a manufacturing defect
claim against the manufacturer of a medical device. Id. at 4. The Dougherty court discussed the
Pennsylvania Superior Court decision in Lance v. Wyeth, where the Superior Court found there were no
state law cases barring strict-liability manufacturing defect claims against a manufacturer of prescription
drugs or devices. 4 A.3d 160, 164-65 (Pa. Super. 2010). However, the Superior Court decision in Lance
which was relied upon by the Dougherty court was subsequently partially overturned on appeal to the
Pennsylvania Supreme Court, when the Court stated that there is a bar in Pennsylvania as to strict liability
for all prescription drugs. Lance, 85 A.3d at 453.
commerce.” (Compl., ¶ 38.) Plaintiffs’ Complaint further alleges that Defendants
breached their duty and were negligent by “manufacturing the N-Hance System in a
defective condition, manufacturing the N-Hance System such that the product failed, and
manufacturing the N-Hance System such that it failed to perform its intended purpose.”
(Compl. ¶ 39 (a) – (c)).
Although these allegations of Plaintiffs’ Complaint are not extremely specific, I
find that when the complaint is read as a whole, there is sufficient specificity as to the
alleged manufacturing defect to meet the Rule 8 requirement of a “short and plain
statement of the claim.” Specifically, paragraphs 18 through 26 of Plaintiffs’ Complaint,
when viewed “in the light most favorable to the non-moving party,” contain enough
factual specificity regarding the defect in this matter to allow this claim to proceed.
Therefore, I will deny Defendants’ Motion to Dismiss on the manufacturing defect claim.
2. Negligent marketing claim
Next, Defendants claim that Plaintiffs’ Complaint is unclear as to what kind of
negligence claim they are asserting for “marketing and/or selling a defective and
unreasonably dangerous product,” as Pennsylvania “recognizes only a very narrow claim
for negligent marketing when a manufacturer over-promotes a drug that nullifies
adequate warnings.” (Defs’ Mtn, p. 13.) Plaintiffs do not argue that their broad negligent
marketing claim should be permitted to remain, and their Complaint contains no
allegations regarding Defendants’ alleged “over-promotion” of the N-Hance System that
would be recognized in Pennsylvania as a valid negligent marketing claim. Accordingly,
I will grant Defendants’ Motion to Dismiss as to any negligent marketing claim being
alleged by Plaintiffs.
3. Negligent design claim
Defendants claim that for a negligent design theory to survive a motion to
dismiss, “at a minimum, federal pleading standards require Plaintiffs to specify the nature
of the alleged product defect,” and that Plaintiffs here have failed to identify the alleged
design defect in the Synthes device. (Defs’ Mtn, pp. 14-15.)
As to the negligent design claim, Plaintiffs’ Complaint states as follows:
Defendants defectively designed the N-Hance device, including the device
implanted in Plaintiff, by allowing unlimited and unrestricted
manipulations of the device during formation prior to implant. Each bend
during the formation process causes surface fractures that ultimately
reduce the integrity of the device. As the device becomes weaker, it is
more susceptible to premature failure, like the N-Hance device implanted
in James Wilson.
(Compl., ¶ 17.)
I find this paragraph of Plaintiffs’ Complaint is sufficiently specific to
identify the alleged design defect in Defendants’ product. No greater specificity is
required, and I will therefore deny Defendants’ Motion to Dismiss as to the
negligent design claim.
4. Failure to warn claim
Defendants also move to dismiss Plaintiffs’ failure to warn claim, alleging that
Plaintiffs failed to address how Defendants breached a duty to Plaintiffs’ doctor and how
a better warning would have affected his doctor’s choice of device. (Defs’ Mtn, p. 16.) It
is well-established that a “manufacturer’s duty to warn is directed to physicians.” Lance
v. Wyeth, 85 A.3d 434, 438 n. 6 (Pa. 2014). Plaintiffs’ Complaint alleges that
Defendants were negligent by failing to adequately warn health care providers that the NHance system could fail, failing to adequately warn health care providers of storage and
handling requirements, and by failing to adequately warn health care providers of
manufacturing defects. (Compl., ¶ 39 (e) – (g)). When the Complaint is read together as a
whole, I find that these allegations are sufficiently pled in order to allege that defendants
failed to exercise reasonable care in informing Plaintiffs’ doctors of any alleged defects
in the N-Hance system, thereby depriving Plaintiff of advice from a fully informed
physician. Accordingly, Defendants’ Motion is denied as to Plaintiff’s failure to warn
C. Negligence Per Se Claims
Lastly, Defendants argue that Plaintiffs’ negligence per se claim fails as a matter
of law, as “Plaintiffs’ claim for negligence per se is based on Synthes’ alleged violations
of the Federal Food, Drug and Cosmetic Act (“FDCA”) and it implementing regulations,”
and that the FDCA “forbids private causes of action.” (Defs’ Mtn at pp. 17-18, citing
Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). I will deny Defendants’
Motion to Dismiss as to Plaintiffs’ negligence per se claims without prejudice, and allow
Defendants to reassert this issue at the time of summary judgment, if warranted.
For the foregoing reasons, Defendants’ Motion to Dismiss Plaintiff’s Complaint is
granted in part and denied in part.
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