WAGNER v. KIMBERLY-CLARK CORPORATION
MEMORANDUM AND/OR OPINION. SIGNED BY HONORABLE LAWRENCE F. STENGEL ON 12/1/2016. 12/2/2016 ENTERED AND COPIES E-MAILED.(sg, )
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
PAUL WAGNER, Individually and as
Executor of the ESTATE OF REGINA
DEC 0 1 2016
IN, Interim Clerk
December J , 2016
This is a wrongful death and survival action under Pennsylvania law. The
plaintiffs product liability claims against Kimberly-Clark Corporation relate to the
defendant's design and manufacture of a feeding tube. The feeding tube was placed in
Regina Wagner's body prior to her death. Kimberly-Clark filed a motion to dismiss
plaintiffs strict liability claim (Count II) and breach of warranty claim (Count III). 1 I will
grant Kimberly-Clark's motion to dismiss the breach of warranty claim, but I will deny
Kimberly-Clark's motion to dismiss the manufacturing defect claim.
Kimberly-Clark has not moved to dismiss plaintiffs negligence claim (Count I). Kimberly-Clark indicates
that it will file an Answer with respect to that claim "once a determination has been made on this Motion." (Doc.
No. 5 at 1 n.l).
The decedent, Regina Wagner, suffered from Amyotrophic Lateral Sclerosis
("ALS"), commonly known as Lou Gehrig's disease. (Compl. i15). Due to her ALS, Ms.
Wagner experienced dysphagia: difficulty or discomfort in swallowing. (Id.). Because of
these complications, she arranged to have a percutaneous gastrostomy tube (i.e., a feeding
tube) placement procedure. (Id.)
In 2014, Ms. Wagner went to Hershey Medical Center to have the feeding tube
installed. (Id.) While her anesthesia was being administered, she suffered an adverse
reaction that caused her to stop breathing. (Id. i16). After she recovered, Ms. Wagner
made arrangements to come back to Hershey Medical Center at a later date for the
procedure. (Id. i17). Ms. Wagner returned to Hershey Medical Center on March 26, 2014,
for placement of the feeding tube. (Id. i18). During this procedure, a part of the feeding
tube-the dilator-"popped into [Ms. Wagner's] stomach and was un-retrievable." (Id. i1
9). The medical staff determined that they could retrieve the dilator from Ms. Wagner's
stomach. (Id.) Nevertheless, they determined that to do so would be unsafe "given the
stiffness of the overlapping dilators." (Id.)
Medical staff performed an upper endoscopy for the purpose of removing the
dilator from Ms. Wagner's stomach. (Id. i110). The dilator was able to be dislodged. (Id.)
However, during this upper endoscopy, Ms. Wagner's oxygen saturations dropped
Because this is a motion to dismiss for failure to state a claim, I will "accept all [plaintiffs] factual
allegations as true" and "construe the complaint in the light most favorable to the plaintiff." Bruni v. City of
Pittsburgh, 824 F.3d 353, 360 (3d Cir. 2016). However, my acceptance of all allegations as true does not apply to
"legal conclusions." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).
multiple times. (Id.
'il 11). The medical staff "felt that the size of the object and the lack of
flexibility" would have caused damage had they attempted to remove the dilator through
Ms. Wagner's throat. (Id.
'i! 10). Therefore, the emergency general surgery department
was consulted to perform an exploratory laparotomy to remove the dilator. (Id.
'il 12). Dr.
Quac Thai Vu was ultimately able to remove the dilator by performing this procedure.
(Id. 'il'il 13-14). During this procedure, Dr. Vu had to create a "new open gastrostomy
feeing [sic] tube." (Id.
After this surgery, Ms. Wagner stayed in the hospital for four days, and was
discharged on March 30, 2014. (Id. 'i! 16). Following her discharge, Ms. Wagner's ALS
"progressed rapidly." (Id. 'il 17). Ms. Wagner died on June 13, 2015. (Id. 'il 18). Ms.
Wagner's husband, Paul Wagner, commenced this action, as Executor of Ms. Wagner's
estate, by filing a complaint in the Court of Common Pleas of Philadelphia on July 12,
2016. Kimberly-Clark removed the action to this Court on August 3, 2016. One week
later, Kimberly-Clark filed this motion to dismiss.
Under Rule 12(b)(6), a defendant bears the burden of demonstrating that the
plaintiff has not stated a claim upon which relief can be granted. Fed. R. Civ. P. 12(b)(6);
see also Hedges v. United States, 404 F.3d 744, 750 (3d Cir. 2005). In Bell Atlantic
Corp. v. Twombly, 550 U.S. 544 (2007), the United States Supreme Court recognized
that "a plaintiff's obligation to provide the 'grounds' of his 'entitle[ment] to relief'
requires more than labels and conclusions, and a formulaic recitation of the elements of a
cause of action will not do." Id. at 555. Subsequently, in Ashcroft v. Iqbal, 556 U.S. 662
(2009), the Supreme Court defined a two-pronged approach to a court's review of a
motion to dismiss. "First, the tenet that a court must accept as true all of the allegations
contained in a complaint is inapplicable to legal conclusions. Threadbare recitals of the
elements of a cause of action, supported by mere conclusory statements, do not suffice."
Id. at 678. Thus, while "Rule 8 marks a notable and generous departure from the hypertechnical, code-pleading regime of a prior era ... it does not unlock the doors of
discovery for a plaintiff armed with nothing more than conclusions." Id. at 678-79.
Second, the Supreme Court emphasized that "only a complaint that states a
plausible claim for relief survives a motion to dismiss." Id. at 679. "Determining whether
a complaint states a plausible claim for relief will, as the Court of Appeals observed, be a
context-specific task that requires the reviewing court to draw on its judicial experience
and common sense." Id. A complaint does not show an entitlement to relief when the
well-pleaded facts do not permit the court to infer more than the mere possibility of
misconduct. Id.; see also Phillips v. Cnty. of Allegheny, 515 F.3d 224, 232-34 (3d Cir.
2008) (holding that: (1) factual allegations of complaint must provide notice to defendant;
(2) complaint must allege facts suggestive of the proscribed conduct; and (3) the
complaint's "'factual allegations must be enough to raise a right to relief above the
speculative level."' (quoting Twombly, 550 U.S. at 555)).
The basic tenets of the Rule 12(b)(6) standard of review have remained static.
Spence v. Brownsville Area Sch. Dist., No. Civ.A.08-626, 2008 WL 2779079, at *2
(W.D. Pa. July 15, 2008). The general rules of pleading still require only a short and
plain statement of the claim showing that the pleader is entitled to relief and need not
contain detailed factual allegations. Phillips, 515 F.3d at 233. Further, the court must
"accept all factual allegations in the complaint as true and view them in the light most
favorable to the plaintiff." Buck v. Hampton Twp. Sch. Dist., 452 F.3d 256, 260 (3d Cir.
2006). Finally, the court must "determine whether, under any reasonable reading of the
complaint, the plaintiff may be entitled to relief." Pinkerton v. Roche Holdings Ltd., 292
F.3d 361, 374 n.7 (3d Cir. 2002).
Kimberly-Clark contends that Pennsylvania law does not recognize strict liability
claims against medical device manufacturers. Kimberly-Clark makes the same argument
on the breach of warranty claim and argues that plaintiffs express warranty claim is
Strict Liability Claim (Count II)
The issue here is whether Pennsylvania recognizes a cause of action for strict
liability against manufacturers of medical devices. The Pennsylvania Supreme Court has
not yet ruled on this issue. A resolution of this motion requires a prediction of how the
Pennsylvania Supreme Court would rule on this issue. Barrier v. Simplicity Mfg., Inc.,
563 F.3d 38, 45-46 (3d Cir. 2009) ("In the absence of a controlling decision by the
Pennsylvania Supreme Court, a federal court applying that state's substantive law must
predict how Pennsylvania's highest court would decide this case."). A federal district
court in this position should consider "relevant state precedents, analogous decisions,
considered dicta, scholarly works, and any other reliable data tending convincingly to
show how the highest court in the state would decide the issue at hand." Id. at 46 (quoting
McKenna v. Ortho Phann. Corp., 622 F.2d 657, 663 (3d Cir. 1980)). From the sources
available, it appears that the Pennsylvania Supreme Court would permit a cause of action
against medical device manufacturers under a "manufacturing" defect theory of strict
liability. Accordingly, I will deny Kimberly-Clark's motion to dismiss plaintiffs strict
liability claim. 3
Pennsylvania has adopted the Restatement (Second) of Torts§ 402A in product
liability cases. Tincher v. Omega Flex, Inc., 104 A.3d 328, 415 (Pa. 2014). At issue in
this case is Comment k to § 402A of the Restatement, which deals specifically with
"unavoidably unsafe products." See Restatement (Second) of Torts § 402A cmt. k.
Comment k 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." Id. According to Comment k, "[t]he
seller of such products, again with the qualification that they are properly prepared and
marketed, and proper warning is given, where the situation calls for it, is not to be held to
strict liability for unfortunate consequences attending their use." Id.
In 1996, the Pennsylvania Supreme Court relied on Comment k in holding that
strict liability cannot be the basis for a cause of action against a drug manufacturer for
failure to warn. Hahn v. Richter, 673 A.2d 888, 891 (Pa. 1996). 4 Years later, the
Because I find that Pennsylvania law does not recognize such a claim under either a "design defect" or
"failure to warn" theory, I will dismiss the plaintiffs strict liability claim to the extent that it is based upon either of
these theories of liability.
Pennsylvania Supreme Court reiterated that "for policy reasons, this Court has declined
to extend strict liability into the prescription drug arena." Lance v. Wyeth, 85 A.3d 434,
453 (Pa. 2014). Following the Hahn decision, the Pennsylvania Superior Court applied
Comment k to medical devices, "find[ing] no reason why the same rationale applicable to
prescription drugs may not be applied to medical devices." Creazzo v. Medtronic, Inc.,
903 A.2d 24, 31 (Pa. Super. Ct. 2006). The Pennsylvania Supreme Court has yet to
address this issue.
It appears that Pennsylvania courts have considered product liability cases against
medical device manufacturers. See Beard v. Johnson & Johnson, Inc., 41 A.3d 823, 83637 (Pa. 2012) (acknowledging without criticism that the plaintiff brought a "product
liability action" against a medical device manufacturer under "multiple theories of
liability, including an asserted defective design" of the device). In Beard, the plaintiff
brought a product liability action with respect to a medical device. 41 A.3d at 824.While
the Pennsylvania Supreme Court did not specifically address Comment k to § 402A, it
noted the case dealt with "a medical-device product liability action in which a strictliability, design-defect theory was asserted." Id. Ultimately, the Pennsylvania Supreme
Court affirmed the granting of judgment for the defendant based on the lower court's
application of the risk-utility test used in product liability cases. Id. at 121-22. 5
Pennsylvania recognizes three separate types of claims for strict liability: (1) design defect; (2)
manufacturing defect; and (3) failure to warn. Phillips v. A-Best Prods. Co., 665 A.2d 1167, 1170 (Pa. 1995).
Under Pennsylvania law, "[t)he question of whether a product is unreasonably dangerous is a question of
law." Riley v. Warren Mfa .. Inc., 688 A.2d 221, 224 (Pa. Super. Ct. 1997). In deciding this question, courts apply a
risk-utility test. Id. at 224-25. This risk-utility test considers several factors, such as the product's utility to the
public versus its risk of causing injury. Id. at 225. After applying this test to a product liability claim, if a court finds
as a matter of law that the product is not unreasonably dangerous then it may dismiss the claim on that basis.
Federal Courts' Interpretations of Pennsylvania Law
Some federal courts have concluded that Comment k's preclusion of strict liability
claims against prescription drug manufacturers applies equally to product liability claims
against medical device
Wilson v. Synthes USA Prods., LLC, 116 F.
Supp. 3d 463, 466 (E.D. Pa. 2015) (collecting cases). Other federal courts see
Pennsylvania law differently. These courts have found that, although Pennsylvania law
prohibits strict liability claims based on a "design" defect or a "failure to warn," it does
not prohibit strict liability claims against medical device and drug manufacturers for
"manufacturing" defects. E.g., Bergstresser v. Bristol-Myers Squibb Co., No. 12-1464,
2013 WL 1760525, at *2 (M.D. Pa. Apr. 24, 2013) (concluding that "although
Pennsylvania law does not recognize a strict-liability claim based on a design defect or a
failure to warn as a viable cause of action against a manufacturer of prescription drugs or
devices, Pennsylvania law does not preclude a strict-liability claim based on a
manufacturing defect"); Tatum v. Takeda Pharms. N. Am., Inc., Civ. Action No. 121114, 2012 WL 5182895, at *2 (E.D. Pa. Oct. 19, 2012) (agreeing with the rationale
espoused by some courts that "strict liability claims for manufacturing defects are not
prohibited" against drug manufacturers); Dougherty v. C.R. Bard, Inc., Civ. Action No.
11-6048, 2012 WL 2940727, at *4 (E.D. Pa. July 18, 2012) (William H. Yohn, J.)
(concluding the same in part because "the Pennsylvania Supreme Court has not ...
addressed the 'properly prepared' condition ... or otherwise discussed whether comment
k's exemption from strict liability extends to manufacturing-defect claims"); 6 Kline v.
Zimmer Holdings, Inc., Civ. Action No. 13-513, 2013 WL 3279797, at *5 (W.D. Pa.
June 27, 2013) (allowing manufacturing-defect claim to proceed after finding that "the
Pennsylvania Supreme Court has not extended its application of comment k to
manufacturing defect claims"); Killen v. Stryker Spine, Civ. Action No. 11-1508, 2012
WL 4498865, at *4 (W.D. Pa. Sept. 28, 2012) (adopting "the rationale ... that while
Hahn instructs that strict liability applies to failure to warn claims, comment k's
exemption from strict liability does not extend to manufacturing defects" in denying
motion to dismiss product liability claim against manufacturer of a medical device).
These rulings seem consistent with the Pennsylvania Supreme Court's recent statement:
"No product is expressly exempt [from strict liability] and, as a result, the presumption is
that strict liability may be available with respect to any product, provided that the
evidence is sufficient to prove a defect." Tincher, 104 A.3d at 386. The term "any
product" as used in Tincher would likely include a medical device.
There is every good reason to believe the Pennsylvania Supreme Court would
extend its product liability jurisprudence to manufacturing defects in medical devices.
Recent rulings from the Pennsylvania Supreme Court reflect its desire to apply § 402A
broadly. As recently as 2012, the Pennsylvania Supreme Court addressed "a medicaldevice product liability action in which a strict-liability, design-defect theory was
The "properly prepared" exception referred to here comes from Comment k, which states that sellers of
unavoidably dangerous products are "not to be held to strict liability" so long as those products are "properly
prepared." Restatement (Second) of Torts§ 402A cmt. k.
asserted." Beard, 41 A.3d at 824. The claim was brought against a medical device
manufacturer. Id. at 825. Although the Pennsylvania Supreme Court affirmed the lower
court's grant of judgment for the defendant, it did so because it found the court had
properly applied the risk-utility analysis used in product liability cases. Id. at 836-37.
There was no statement, or even implication, that such a claim is not allowed under
Pennsylvania law. Cf. Creazzo, 903 A.2d at 31 (finding "no reason why the same
rationale applicable to prescription drugs may not be applied to medical devices" in
dismissing strict liability claim against medical device manufacturer).
Indeed, it is telling that in the decade since the Pennsylvania Superior Court
decided Creazzo, the Pennsylvania Supreme Court has only cited Creazzo one time in a
footnote. 7 It has never relied on, adopted, or even addressed Creazzo' s rationale that
medical device manufacturers cannot be subject to strict liability claims. This certainly
calls into question other courts' assumptions that the Pennsylvania Supreme Court would
adopt Creazzo and apply Comment k to medical device manufacturers in the same way it
has applied Comment k to prescription drug manufacturers. In fact, quite the opposite can
be inferred from the Pennsylvania Supreme Court's decisional law. For example, it
recently reviewed the viability of Pennsylvania's entire product liability law in Tincher v.
Omega Flex, Inc., 104 A.3d 328, 415 (Pa. 2014). In doing so, the Pennsylvania Supreme
Court went out of its way to emphasize strongly, for the first time ever, that "any"
product may form the basis for strict liability:
The citation had nothing to do with whether or not a strict liability claim against a medical device
manufacturer was allowable. Rather, it referred to the principle of spoliation of evidence, which was another
(unrelated) aspect of the Creazzo case. Pyeritz v. Commonwealth, 32 A.3d 687, 692 n.5 (Pa. 2011).
No product is expressly exempt [from strict liability] and, as a result, the
presumption is that strict liability may be available with respect to any
product, provided that the evidence is sufficient to prove a defect. See
Restatement (2d) of Torts § 402A cmt. b (cause of action in strict liability
"cover[s] the sale of any product which, if it should prove to be defective,
may be expected to cause physical harm to the consumer or his property")
104 A.3d at 386 (emphasis in original). 8 The Beard and Tincher cases provide a sufficient
basis for me to predict that, if faced with this issue, the Pennsylvania Supreme Court
would permit strict liability claims against medical device manufacturers.
In addition to recent case law, there are other reasons to believe the Pennsylvania
Supreme Court would allow manufacturing defect claims against medical device
manufacturers. The language of Comment k itself contains an express prerequisite for a
product to be deemed "unavoidably unsafe" and thus exempt from strict liability. This
prerequisite is that the product must be "properly prepared." Restatement (Second) of
Torts§ 402A cmt. k. Indeed, Comment k affirmatively states that this "properly
prepared" language is a prerequisite: "The seller of such products, again with the
qualification that they are properly prepared . .. is not to be held to strict liability." Id.
(emphasis added). In Dougherty, Judge Yohn recognized this language in concluding that
Pennsylvania law does not prohibit a medical-device strict liability claim based on a
manufacturing defect. 2012 WL 2940727, at *3. In the same vein, he recognized that few
of the cases that find Pennsylvania law to preclude such a claim have addressed the
The Court did note its holding in Hahn, which affirmed the inapplicability of strict liability to prescription
drug manufacturers. However, this was the only exception, cited by the Court, to the general rule that manufacturers
of"any product" may be strictly liable. Ifit had intended to apply Hahn to medical device manufacturers, the
Pennsylvania Supreme Court would have. But they did not. See Tincher, 104 A.3d at 386 (recognizing Hahn's
holding that "manufacturer[s] [are] immune from strict liability defective design claim[s] premised upon sale of
prescription drugs without adequate warning") (emphasis added).
"properly prepared" language or distinguished the three types of strict liability claims. Id.
at *4. The Eastern District of Pennsylvania decision in Dougherty makes sense. The
plain language of Comment k rightly recognizes that, in order for a product to be deemed
"unavoidably" unsafe, it must have been prepared properly. If this were not the case,
manufacturers could exercise no care at all in the preparation of their products, but then
be able to enjoy the argument that their product was "unavoidably" dangerous. Such an
approach defies logic and fairness since, if little-or no-care is exercised in the
preparation (i.e. manufacturing) of a product, then the product's danger is certainly not
"unavoidable." The Pennsylvania Supreme Court is unlikely to take such an approach.
Relevant scholarly works support the position adopted in Dougherty. In the
absence of specific direction from the Pennsylvania Supreme Court, "scholarly works"
are appropriate resources "tending convincingly to show how the [Pennsylvania Supreme
Court] would decide the issue at hand." Barrier, 563 F .3d at 46. In Tincher, the
Pennsylvania Supreme Court relied on a scholarly article by William Prosser, a renowned
torts scholar. Id. (citing William L. Prosser, The Assault Upon the Citadel (Strict
Liability to the Consumer), 69 Yale L.J. 1099, 1103-04 (1960)). Its reliance on Prosser
for this proposition-that "all" products fall under strict liability-indicates that the
Court would likely find strict liability claims based on manufacturing defects against
medical device manufacturers viable. There is further support, in case law and academia,
Kimberly-Clark relies on Wilson v. Synthes USA Products, LLC, 116 F. Supp. 3d 463 (E.D. Pa. 2015)
and argues that, since this case is more recent than Dougherty and other case law following Dougherty's approach, I
should follow the dictates of Wilson. However, regardless of its date, Wilson is still just one among many federal
district court cases interpreting Pennsylvania law. These cases are clearly split on how they rule on this issue.
Wilson's precedential value is equally-not more-persuasive than the other federal district cases. Also, it does
nothing to call into question Pennsylvania case law that I have relied on-namely, Beard and Tincher.
suggesting that Comment k views manufacturing defect claims differently than other
types of strict liability claims. See Dougherty, 2012 WL 2940727, at *5 ("Courts and
commentators thus generally agree that comment k's immunity from strict liability does
not extend to manufacturing defects.").
I find that Pennsylvania law does not preclude a strict liability claim based on a
"manufacturing" defect and I predict the Pennsylvania Supreme Court would permit a
strict liability claim for a manufacturing defect in a medical device.
Breach of Warranty Claim (Count III)
Plaintiff does not oppose Kimberly-Clark's motion to dismiss the breach of
warranty claim in Count III. (Doc. No. 6 at 1). Accordingly, I will grant KimberlyClark's motion to dismiss Count III with prejudice.
Because plaintiffs strict liability claims based on design defect and failure to warn
arr not cognizable under Pennsylvania law, I will strike with prejudice all language in
plaintiffs complaint that relates to a "design" defect or "failure to warn." I will deny
Kimberly-Clark's motion to dismiss plaintiffs strict liability claim to the extent that
plaintiff pleads that claim based on a manufacturing defect. Finally, because plaintiff
does not oppose the dismissal of its breach of warranty claim, I will dismiss Count III
An appropriate Order follows.
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